🔍 RecallPedia

Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments Indications for Use: AutoFIX" cannu lated screws are indicated for the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotom ies geared towards a functionally stable osteosynthesis in small bones.

Class I - Dangerous
🏥 Medical Devices Recalled: May 19, 2014 Small Bone Innovations Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    All lots
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Small Bone Innovations
Reason for Recall:
Small Bone Innovations (SBi) is recalling all lots of 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments to update the IFU.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments Indications for Use: AutoFIX" cannu lated screws are indicated for the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotom ies geared towards a functionally stable osteosynthesis in small bones.

Product Codes/Lot Numbers:

All lots

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2127-2014

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